Integrating Treatment for Mental Disorders in Methadone Clinics in Ukraine
Ukraine trial integrates mental health care into methadone clinics
Plain English Summary
Integrating Treatment for Mental Disorders in Methadone Clinics in Ukraine is a Not Applicable clinical trial sponsored by Ukrainian Institute on Public Health Policy studying Depression, Opioid Use Disorder. This study tests new ways to provide mental health treatment within clinics that offer methadone for opioid use disorder. It is designed for patients in Ukraine who are receiving methadone treatment and may also have mental health conditions like depression. Participation involves receiving standard care or enhanced care through telehealth and financial incentives, with mental health assessments. Alternatives include seeking mental health services separately from methadone treatment, which may be less integrated. The trial aims to enroll 1350 participants.
Official Summary
The MEDIUM study (U01DA045384) is a cluster-randomized trial based in Ukraine. The main goal of the study is to test the implementation strategies for mental health treatment services in OAT clinics. The study enrolled 12 OAT clinics from 12 geographically and epidemiologically diverse regions and randomized them 1:1:1 to three implementation arms: standard of care (SoC), ECHO facilitation, and ECHO plus pay-for-performance (P4P) incentives. Project ECHO, is an evidence-based telehealth intervention, connecting clinicians with national experts for short thematic didactic sessions and case discussions. All sites are provided with a modified Screening, Brief Intervention and Referral to Treatment (mSBIRT) intervention manual for mental disorders and regular supply of two selective serotonin reuptake inhibitors (SSRI) medications. All current and new patients at participating sites (N\~2000 at study start) are automatically eligible for SSRI prescription. The main outcomes of the study are the elements of mental health continuum of care (screening, diagnosis, treatment and retention). These outcomes are assessed in the entire patient population using de-personalized data extracted from the electronic medical record system. A sub-sample of patients (N=1,350) was recruited into a cohort and consented to assess prevalence and severity of mental disorders, various factors related to the uptake of and retention in mental health treatment (addiction severity, other substance use, co-morbidities), as well as other important covariates. These assessments are done at baseline, 6, 12, 18 and 24 months after enrollment.
Who Can Participate
Here is what you need to know about eligibility for this trial. Anyone receiving methadone treatment at a participating clinic in Ukraine can join. You cannot join if you are unwilling or unable to give your informed consent. There are no specific age or health requirements beyond being a patient in the methadone program. This trial is studying Depression, Opioid Use Disorder, so participants generally need a confirmed diagnosis.
What They're Measuring
The study measures how many patients are screened for depression, assessed by a doctor, start taking antidepressant medication, and continue taking it, indicating better management of depression along The specific primary outcome measures are: Proportion of patients screened for depression by clinical staff using Patient Health Questionnaire-2 (PHQ-2) (30 months (August 2019 - February 2022)); Proportion of patients assessed by physician using Montgomery-Asberg Depression Rating Scale (MADRS) and motivated for treatment (30 months (August 2019 - February 2022)); Proportion of patients initiated on Selective serotonin reuptake inhibitors (SSRIs) (30 months (August 2019 - February 2022)); Proportion of patients retained on Selective serotonin reuptake inhibitors (SSRIs) (30 months (August 2019 - February 2022)). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This trial is important because it aims to improve mental health care access for individuals with opioid use disorder in Ukraine, addressing a significant gap in integrated treatment. This research targets Depression, Opioid Use Disorder, where improved treatment options are needed.
Investor Insight
This trial signals a growing focus on integrated care models for substance use and mental health, a large and underserved market, with potential for scalable telehealth solutions. The large enrollment target of 1350 participants suggests significant investment in this program.
Is This Trial Right for Me?
Ask your doctor if this integrated approach is right for you and what mental health services are available. Day-to-day involvement includes attending your regular methadone clinic appointments and potentially participating in mental health screenings and assessments. You may be offered new or different ways to access mental health support through telehealth or other programs. The trial is being conducted at 9 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: PARALLEL
- Masking: NONE
- Enrollment: 1,350 participants
Interventions
- OTHER: Project ECHO — Project Extension for Community Healthcare Outcomes® (ECHO): This EBP, tested originally to facilitate HCV care into non-specialty settings, is based on established educational theories of social learning \& behavior change in where non-specialists collaborate with specialists, resulting in an innovative healthcare delivery model that results in equivalent quality care for patients in non-specialty settings.
- OTHER: Payment for Performance — P4P in healthcare, endorsed by 3 IOM reports, gives financial incentives to clinicians for adhering to clinical guidelines and achieving better health outcomes. One 2007 IOM report recommended "physician incentives so that profitability and improved healthcare delivery is aligned with patient safety goals and strengthen the business case for healthcare quality and safety."
Primary Outcomes
- Proportion of patients screened for depression by clinical staff using Patient Health Questionnaire-2 (PHQ-2) (30 months (August 2019 - February 2022))
- Proportion of patients assessed by physician using Montgomery-Asberg Depression Rating Scale (MADRS) and motivated for treatment (30 months (August 2019 - February 2022))
- Proportion of patients initiated on Selective serotonin reuptake inhibitors (SSRIs) (30 months (August 2019 - February 2022))
- Proportion of patients retained on Selective serotonin reuptake inhibitors (SSRIs) (30 months (August 2019 - February 2022))
Secondary Outcomes
- Number of participants who continue opioid agonist treatment at the assessment time point (3, 6, 12, 18 and 24 months after enrollment for each patient)
- Psychiatric Quality of Life (SF-12 mental component score) changes over time (3, 6, 12, 18 and 24 months after enrollment for each patient)
Full Eligibility Criteria
Inclusion Criteria: * All patients receiving OAT at participating sites Exclusion Criteria: * Not willing to participate * Unable to sign informed consent
Trial Locations
- Kryvyi Rig psycho-neurological dispensary, Kryvyi Rih, Dnipropetrovsk Oblast, Ukraine
- Dnipropetrovsk narcological dispensary, Pavlohrad, Dnipropetrovsk Oblast, Ukraine
- Kropyvnitsky regional narcological dispensary, Kropyvnytskyi, Kirovohrad Oblast, Ukraine
- Mykolaiv regional narcological dispensary, Mykolayiv, Mykolaiv Oblast, Ukraine
- Ternopil regional narcological dispensary, Ternopil, Ternopil Oblast, Ukraine
- Ivano-Frankivsk regional narcological dispensary, Ivano-Frankivsk, Ukraine
- Kyiv city narcological clinic 'Sociotherapia', Kyiv, Ukraine
- Mykolaiv City Hospital #5, Mykolayiv, Ukraine
- Vinnitsia regional narcological dispensary 'Sociotherapia', Vinnytsia, Ukraine
Frequently Asked Questions
What is clinical trial NCT05646212?
NCT05646212 is a Not Applicable INTERVENTIONAL study titled "Integrating Treatment for Mental Disorders in Methadone Clinics in Ukraine." It is currently active, not recruiting and is sponsored by Ukrainian Institute on Public Health Policy. The trial targets enrollment of 1350 participants.
What conditions does NCT05646212 study?
This trial investigates treatments for Depression, Opioid Use Disorder. The primary condition under study is Depression.
What treatments are being tested in NCT05646212?
The interventions being studied include: Project ECHO (OTHER), Payment for Performance (OTHER). Project Extension for Community Healthcare Outcomes® (ECHO): This EBP, tested originally to facilitate HCV care into non-specialty settings, is based on established educational theories of social learning \& behavior change in where non-specialists collaborate with specialists, resulting in an innovative healthcare delivery model that results in equivalent quality care for patients in non-specialty settings.
What does Not Applicable mean for NCT05646212?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT05646212?
This trial is currently "Active, Not Recruiting." It started on 2018-07-01. The estimated completion date is 2026-05-31.
Who is sponsoring NCT05646212?
NCT05646212 is sponsored by Ukrainian Institute on Public Health Policy. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT05646212?
The trial aims to enroll 1350 participants. The trial status is active, not recruiting.
How is NCT05646212 designed?
This is a interventional study, uses randomized allocation, follows a parallel design, employs none masking.
What are the primary outcomes being measured in NCT05646212?
The primary outcome measures are: Proportion of patients screened for depression by clinical staff using Patient Health Questionnaire-2 (PHQ-2) (30 months (August 2019 - February 2022)); Proportion of patients assessed by physician using Montgomery-Asberg Depression Rating Scale (MADRS) and motivated for treatment (30 months (August 2019 - February 2022)); Proportion of patients initiated on Selective serotonin reuptake inhibitors (SSRIs) (30 months (August 2019 - February 2022)); Proportion of patients retained on Selective serotonin reuptake inhibitors (SSRIs) (30 months (August 2019 - February 2022)). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT05646212 being conducted?
This trial is being conducted at 9 sites, including Kryvyi Rih, Dnipropetrovsk Oblast; Pavlohrad, Dnipropetrovsk Oblast; Kropyvnytskyi, Kirovohrad Oblast; Mykolayiv, Mykolaiv Oblast and 5 more sites (Ukraine).
Where can I find official information about NCT05646212?
The official record for NCT05646212 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT05646212. This government database provides the most up-to-date and detailed information about the trial.
What is NCT05646212 testing in simple terms?
This study tests new ways to provide mental health treatment within clinics that offer methadone for opioid use disorder. It is designed for patients in Ukraine who are receiving methadone treatment and may also have mental health conditions like depression.
Why is this trial significant?
This trial is important because it aims to improve mental health care access for individuals with opioid use disorder in Ukraine, addressing a significant gap in integrated treatment.
What are the potential risks of participating in NCT05646212?
Potential side effects of the antidepressant medications (SSRIs) can include nausea, insomnia, or sexual dysfunction. Some patients might experience temporary worsening of symptoms or feel uncomfortable discussing mental health issues. There's a small risk of not responding to the initial treatment or experiencing withdrawal if medications are stopped abruptly. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT05646212?
Ask your doctor if this integrated approach is right for you and what mental health services are available. Day-to-day involvement includes attending your regular methadone clinic appointments and potentially participating in mental health screenings and assessments. You may be offered new or different ways to access mental health support through telehealth or other programs. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT05646212 signal from an investment perspective?
This trial signals a growing focus on integrated care models for substance use and mental health, a large and underserved market, with potential for scalable telehealth solutions. This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participation involves receiving standard care or enhanced care through telehealth and financial incentives, with mental health assessments. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.